Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Purpose
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
Condition
- Fecal Incontinence
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18 years or older 2. Primary indication of Fecal Incontinence (FI) 3. Willing and capable to provide informed consent and agrees to comply with specified evaluations at selected clinical centers
Exclusion Criteria
- Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints (includes neurological conditions such as multiple sclerosis) 2. Any psychiatric or personality disorder at the discretion of the study participating physician; this may include poor understanding or compliance with trial requirements 3. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone 4. A female who is breastfeeding 5. A female with a positive urine pregnancy test
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Only
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Fecal Incontinence | Participants with the Axonics SNM System Model 5101 and followed up regarding their fecal incontinence symptoms. |
|
Recruiting Locations
Houston Colon
Houston, Texas 77030
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- Axonics, Inc.
Detailed Description
Post-market clinical follow-up for continued assessment of safety and performance of the Axonics INS Model 5101 (R20). The study will include participants with the primary diagnosis of fecal incontinence who are eligible to receive the rechargeable R20 device as per the commercially available IFU.